Infant Cough, Cold Drugs Withdrawn

Oct. 11, 2007 -- The makers of all over-the-counter oral cough and cold medicines for infants announced that they are taking those products off the market.

"Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal," the Consumer Healthcare Products Association (CHPA), a trade group representing the makers and distributors of over-the-counter medicines, states in a news release.

The withdrawal only applies to cough and cold medicines that refer to "infants," not to children who are at least 2 years old.

The CHPA today issued this list of branded cough and cold medicines that are being voluntarily withdrawn:

FDA Reviewing Products

In August, the FDA warned parents not to give children younger than 2 over-the-counter cough or cold medicines unless given specific directions to do so by a health care provider.

The FDA is reviewing the safety and effectiveness of nonprescription cough and cold drug use in children. An FDA panel will discuss the topic next week.

Trade Group's Comments

"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," CHPA President Linda Suydam, DPA, says in a news release.

"The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority," says Suydam.

The CHPA and its member companies have recommended to the FDA that the labels on all over-the-counter cough and cold medicines for children 2 and older be strengthened from "ask a doctor" before using to "do not use" in children under age 2. That way, parents will be aware that these products are not recommended for infants.